| CTRI Number |
CTRI/2025/09/095302 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study between mifepristone and norethisterone for uterine fibroid management. |
|
Scientific Title of Study
|
Comparative study of Mifepristone and Norethisterone for symptomatic relief of heavy menstrual bleeding in uterine myoma- A randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oishi Debnath |
| Designation |
Post graduate resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept of OBG, lady hardinge medical college.
New Delhi
DELHI
110001
India |
| Phone |
9933991146 |
| Fax |
|
| Email |
debnathoishi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ratna Biswas |
| Designation |
director professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept of OBG, lady hardinge medical college.
New Delhi
DELHI
110001
India |
| Phone |
9933991146 |
| Fax |
|
| Email |
debnathoishi11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Oishi Debnath |
| Designation |
Post graduate resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept of OBG, lady hardinge medical college.
New Delhi
DELHI
110001
India |
| Phone |
9933991146 |
| Fax |
|
| Email |
debnathoishi11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
| NIL |
|
|
Primary Sponsor
|
| Name |
LHMC, New Delhi. |
| Address |
Shaheed Bhagat singh marg, New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Oishi Debnath |
Lady Hardinge Medical College & SSK Hospital, New Delhi. |
LHMC Shaheed Bhagat Singh Marg, New Delhi 110001
New Delhi
DELHI |
9933991146
debnathoishi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Mifepristone)
|
Group A (Mifepristone): Tab. Mifepristone 25 mg orally once
daily for 3 months.
|
| Comparator Agent |
Group B (Norethisterone) |
Group B (Norethisterone): Tab. Norethisterone 10 mg TDS ×
3 days, then 10 mg BD × 3 days, then 5 mg BD × 15 days (for
max 3 cycles). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with uterine myoma more than 2cm on ultrasound.
PBAC score more than or equal to 100(heavy menstrual bleeding) |
|
| ExclusionCriteria |
| Details |
Coagulation disorders.
History of thromboembolic events (DVT, PE)
Malignancy of reproductive tract.
Known allergy to mifepristone/norethisterone.
Concurrent hormonal therapy use.
Known liver or renal disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in PBAC score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean improvement in hemoglobin levels
|
3 months |
| Mean reduction in myoma volume |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial will compare the efficacy and safety of mifepristone versus norethisterone in women with heavy menstrual bleeding due to uterine myoma. Forty participants aged 30 to 50 years with leiomyomas greater than 2 cm and PBAC score 100 or more will be recruited at Lady Hardinge Medical College New Delhi. Group A will receive mifepristone 25 mg once daily for 3 months while Group B will receive norethisterone in tapering doses for up to three cycles. The primary outcomes are reduction in PBAC score and proportion achieving 50 percent improvement at 3 months. Secondary outcomes include changes in hemoglobin and myoma volume. The trial is sponsored by Lady Hardinge Medical College New Delhi requires no DCGI clearance and is scheduled from August 2025 to November 2026. |